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e-mail: [email protected]
r35k0709
This brochure is presented to demonstrate the surgical technique, patient selection and post-op protocol utilized by Dr. Donald Nuss. As the manufacturer of this device, Biomet Microfixation does not practice medicine
and does not recommend this product or surgical technique for use on a specific patient. The surgeon who performs any implant procedure must determine the appropriate device and surgical procedure for each
individual patient. Devices shown in this brochure may not be cleared or licensed for use or sale in your individual country. Please contact your local distributor for information regarding availability of this product.
Information contained in this brochure is intended for surgeon or distributor information only and is not intended for patient distribution. All surgeries carry risks. For additional information, please see package insert,
or visit our web site at www.biometmicrofixation.com or call 1-800-874-7711.
BMF00-2500
Pectus Bar
Pectus Excavatum Correction
Anticipate. Innovate.
TM
An Innovative Technique for the Correction of Pectus Excavatum
Anticipation and innovation. These two qualities have made Biomet Microfixation
an industry leader. Founded by Walter Lorenz more than thirty years ago, Biomet
Microfixation offers instrumentation, plating systems and related products for a wide
range of surgical procedures. Using the Nuss Technique, along with the Pectus Bar,
surgery to correct Pectus Excavatum is accomplished in less time and with more ease
than with other techniques.
Dr. Donald Nuss, in cooperation with Biomet Microfixation, has developed a minimally
invasive surgical procedure and Pectus Bar implant to remodel the chest wall over
a 2 to 3 year period. The Nuss Technique, also known as the “Minimally Invasive
Repair of Pectus Excavatum”(MIRPE), uses principles of minimal-access surgery and
thoracoscopy combined with the proper placement of a Pectus Bar to achieve
correction of Pectus Excavatum.
Pectus Excavatum is a chest disorder occurring in approximately one of every 1,000
children. This congenital deformity is characterized by a concave, “funnel” shaped
chest. The inward facing sternum can apply pressure to the vital organs of the chest
resulting in restricted organ growth and shortness of breath. Mildly present at birth,
Pectus Excavatum usually becomes more serious throughout childhood, often
magnifying considerably during the teenage years.
Pectus System Features
• The Pectus Bar’s rounded ends and blunt edges help minimize tissue
destruction during implant insertion.
• The Pectus Bar comes in a variety of lengths ranging from 7 inches
(17.8 cm) to 17 inches (43.2 cm) to accommodate most Pectus Excavatum
correction procedures.
• All instruments in the Pectus System are designed to increase simplicity
during the Nuss Procedure.
• The Pectus System Container comes in two sizes and conveniently houses the
entire range of Pectus implants and instruments.
• Specialized titanium bars and stabilizers available for patients with nickel allergies.*
• Pectus-size bars available for the following:
-Special sized bars
-Pre-bent bars developed in accordance with patients’ CT scans*
*Titanium and pre-bent bars for pediatric indications only
Severe case of Pectus Excavatum.
Pre-operative photo.
2 year Post-operative photo at 1 month
after bar removal.
The Nuss Technique
Benefits
Minimally Invasive Operation - Use of the MIRPE technique requires neither
cartilage incision nor resection for correction of pectus excavatum. There
is no need to make an incision in the anterior chest wall, raise pectoralis
muscle flaps, resect rib cartilages, nor perform sternal osteotomy.
Asymptomatic patients are given an exercise program to correct their
posture and are reevaluated every six months to follow their progress.
Patients will be moved into the symptomatic group as indicated by
their symptoms.
Reduces Operating Time - The procedure requires approximately 40 minutes,
as opposed to the 4 to 6 hours required of a chest reconstruction.
Symptomatic patients are sent for a CT scan, pulmonary-function studies
and cardiology examinations. Surgery is supported by the results of the
objective criteria obtained from these exams. The criteria includes a CT
index (Haller index) of 3.2 or greater, atelectasis, abnormal pulmonary
function, cardiac compression, mitral valve prolapse, heart murmurs and
A-V conduction delay. These patients may have other abnormalities, such
as Marfan’s syndrome, Ehlers-Danlos or Poland’s syndrome.
Minimal Blood Loss - Blood loss is generally 10 to 30ccs, compared to the
300ccs lost with the other products and techniques.1
Early Return to Regular Activity - The average time for a patient to resume
daily activities, once treated with the Pectus Bar, is one month.*
* Return time varies depending on each patient. Always consult your physician before resuming any activity.
Chest Correction - Using the Pectus Bar the patient can experience ease
of breathing, normal chest expansion and elasticity, and proper lung and
heart growth.
Excellent Long-Term Cosmetic Result - “A 10 Year Study of a Minimally
Invasive Technique for the Correction of Pectus Excavatum”, indicated
excellent long-term results. The Journal of Pediatric Surgery, 1998; 33(4).
Donald Nuss, M.B., Ch.B.; Robert E. Kelly, Jr., M.D.; Daniel P. Croitoru, M.D.;
Michael E. Katz, M.D.
Prior to the day of surgery, the patient’s chest is measured to determine
the length of the Pectus Bar. Proper measurement is performed utilizing a
measuring tape or a Pectus Bar Template over the deepest portion of the
pectus from the right midaxillary to the left midaxillary line. The length of the
Pectus Bar required is 1 to 2 cm less than the measured distance because
the tape measures the external diameter of the chest and the Pectus Bar
traverses the internal diameter.
Indications and Patient Selection
Patients with pectus excavatum are considered for surgical reconstruction
between the ages of 4 and 18 years, when the ribs and costal cartilage are
neither too malleable nor too rigid. The ideal age is between 8 and 13 years,
prior to the adolescent growth period.
A complete physical exam and full medical history are completed for
all patients to place them into either asymptomatic or symptomatic
classifications based on the following criteria:
• History of progressive worsening of the pectus excavatum.
• History of the symptoms related but not limited to exercise intolerance,
chest pain, and shortness of breath.
• Clinical evaluation showing severe pectus with the demonstration of
cardiac displacement and pulmonary compromise.
Heart compression and displacement
Operative Technique
1. A course of antibiotics is started at the time of surgery to prevent infection and
reduce the development of pneumonia. The procedure is performed under
general endotracheal anesthesia with muscle relaxation and an epidural block
for both operative and postoperative pain control.
1-2
Patient positioned with both arms abducted
2. During the procedure, the patient is positioned with both arms abducted at the
shoulders to allow access to the lateral chest-wall. Padding under the arms and
proper positioning of the arms will help prevent neurologic injury.
3. The patient is draped, and the chest is marked for surgery with a sterile marking
pen. The deepest portion of the pectus is marked. If the deepest point of the
pectus is inferior to the sternum, then mark the lower end of the sternum. Using
this point, establish a horizontal plane across the pectus region by marking the
intercostal spaces at the top of the pectus ridge on both sides. Extend the
horizontal plane to the lateral chest wall and mark between the anterior and
midaxillary lines for transverse lateral incisions.
3
Patient is draped and marked for surgery
4. The preoperative chest measurement is reconfirmed, and a Pectus Bar is
selected for bending into the desired chest-wall curvature. The Pectus Bar
Template can be used to visualize the shape necessary to correct the deformity.
Special care should be taken in choosing the correct Pectus Bar length to
maximize bar stability.
4
Confirming preoperative measurements
using a Pectus Bar Template
5. Using the Pectus Bender, shape the selected Pectus Bar from the
center outward making small gradual bends. Position the cam on the bender
at position “0” (minimum radius) then move the cam to position “1,” and finally to
position “2” (maximum radius). It may be necessary to exaggerate the curvature
slightly to allow for the anterior chest-wall pressure and downward force of the
sternum. To insure proper union between bar and stabilizer, avoid bending the
lateral ends of the Pectus Bar. The selected bar is shaped for each patient
Incisions being made at the predetermined marks
5
The selected bar is shaped for each patient
6. Bilateral 2.5 cm transverse, thoracic incisions are made at the marks previously drawn
in line with the deepest point of the depression in each lateral chest wall between the
anterior and midaxillary lines. A skin tunnel is raised anteriorly from both incisions to the
top of the pectus ridge at the previously selected intercostal space. The Pectus
Bar enters the chest slightly medial to the top of the pectus ridge.
6
Incisions being made at the
predetermined marks
7-8
Advancing the Pectus Bar Introducer to
dissect a tunnel for the pectus bar
7. A 5mm, 0° or 30° thoracoscope is used during the procedure to visualize the chest
organs. Insert the scope on the patient’s right side, one to two intercostal spaces below
the space which has been chosen for the Pectus Bar. The scope can be used
bilaterally using the incision made on the patient’s left, or a new stab incision can be
made one to two intercostal spaces below the space which has been chosen. The
chest is insufflated with CO2 for adequate visualization.
8. Enter the chest from the patient’s right with the proper Pectus Introducer in order
to dissect a tunnel for the implant. The small introducer is for younger, smaller patients,
ages 4-12. The long introducer is for older, larger patients, ages 13-18. Advancing the
Pectus Bar Introducer to dissect a tunnel for the pectus bar.
9. The Pectus Introducer is slowly advanced across the mediastinum immediately
under the sternum and is gently pushed through the intercostal space on the opposite
side. The tip should face anteriorly and stay in contact with the sternum. Advance the
device far enough through the opposite incision to allow for elevating the sternum and
attaching of the umbilical tape.
9
Introducer is advanced through the chest
and the opposite incision
10
Pressure is applied to the sternum to stretch
the connective tissues
10. Elevate the sternum by lifting the advanced introducer from both sides of the
patient. Apply pressure above and below the sternum to obtain the desired
curvature of the sternum. Repeat several times in order to stretch the connective
tissues and correct the deformity prior to inserting the bar. Correcting the pectus
excavatum by elevating the sternum with the introducer greatly facilitates
initial bar rotation and improves bar stability.
Operative Technique
11. Two strands of umbilical tape are tied through the hole in the end of the introducer
and then pulled through the tunnel by withdrawing the introducer from the
patient’s right side. One strand is used as a backup, while the other strand of
umbilical tape is then attached to the bar and used to guide it through the tunnel.
11
Umbilical tape used to guide the bar
12. The curved Pectus Bar is pulled under the body of the sternum from the patients
right side with the convexity facing posteriorly. When the bar is in position, it is
flipped with the Pectus Flipper causing the sternum and anterior chest wall to rise
into the desired position.
12
Guiding the convex bar through the chest
with the convexity facing anteriorly
13
13. STABILITY OF THE BAR MUST BE DETERMINED AT THIS TIME. Such assessment will
dictate the need for bar stabilization and for placement of a second bar behind
the sternum. Typically, patients require one bar. Older, larger and more active
patients or patients with a more severe deformity may require an additional bar to
achieve proper correction and stability. If needed, a second bar is placed one or
two intercostal spaces superiorly or inferiorly to the first bar
Pectus correction and implant stability
are evaluated
14. A subcutaneous pocket is made posteriorly at each incision where the lateral end of the bar will be fitted with a Pectus Bar Stabilizer. One stabilizer is recommended for every bar implanted to limit rotation of the bar. Recommended patient ages for
use of the stabilizers are:
• Patients 4 - 13 years - use one stabilizer per bar implanted
• Patients 14 - 18 years - use one stabilizer per bar implanted, however one may
choose to use two per bar depending on the patient’s pectus, muscular
development, activity level (ie: sports), and the stability of the bar.
14
Trial fitting a stabilizer (01-3801) to the implant
15. An Elongated Stabilizer is chosen and fitted with the channel facing anteriorly and
1 to 2 cm of the lateral end of the bar exposed through the stabilizer. The stabilizer is then
secured to the bar and sutured to the muscle after being properly fitted. The bar and
stabilizer(s) should not be too anterior or posterior on the patient as this can lead to pain
and tissue erosion.
• Elongated Stabilizer - Suitable for all patients in the recommended age range.
15
Trial fitting a stabilizer (01-3801) to the implant
16. The bar and stabilizer are secured to each other and to the chest wall with multiple sutures
to anchor the bar and stabilizer to the chest wall and bury the bar and stabilizer with tissue.
16
Cardiac wire is used to “figure 8” suture
both the bar and the stabilizer
The size and types of suture presently used are as follows:
• If using the LactoSorb stabilizer, secure the stabilizer to the bar with a “figure-8 suture” around
the junction of both devices with size “O” absorbable suture.
• If using the metal stabilizer, secure the stabilizer to the bar with a “figure-8 suture” around the
junction of both devices with No. 3 cardiac wire or size “O” non-absorbable suture.
• Secure the holes in the bar and stabilizer to the chest wall muscles with size “O” absorbable
or non-absorbable suture attached to a UR 6 (right-angle) needle.
• Secure muscle over the bar with “mattress sutures” using size “O” fast or slow absorbable
suture attached to a large needle.
• Close the wound with a small-size, fast-absorbing suture and a dressing.
LactoSorb stabilizer
17. Prior to closing the incisions, place patient in Trendelenburg’s position, inflate lungs and
apply positive end expiratory pressure (PEEP) of 4 to 6 cm H2O to prevent pleural air trapping.
17
Suture to the chest wall muscles to anchor
the device
18
Patient Is ready for recovery
18. A chest radiograph should be obtained postoperatively to check for
pneumothorax. The radiograph is excellent in showing final bar placement
and may be obtained in the operating room or surgery-recovery area,
as required.
Post-operative Patient Care
Patients are kept well sedated for the first 1 to 3 days for postoperative pain
management and to prevent bar displacement. Medications and therapies
depend on the patient’s response to pain and may include the use of an
epidural catheter, intravenous morphine for breakthrough pain, patientcontrolled analgesia (PCA) and oral analgesia.
Once discharged, the patient should maintain good posture and limit activity
for the first month, with regular activity permitted after 4 to 6 weeks. The
following guidelines have been developed to assist the patient’s return to
regular activity and reduce the risk of bar displacement:
Post Operative Patient Handling by the hospital staff is important for avoiding
bar displacement. Patients are discharged from the hospital when they are
able to walk unassisted. The following protocol is recommended:
• Deep-breathing exercises performed twice a day, every morning
and evening
Recommended postoperative protocol
• No waist bending, twisting or log rolling for first four (4) weeks at home
Day 1 Post-Op
• Patient should keep a straight back with no slouching for the first month
• Out of Bed (OOB) to a chair with assistance OOB ambulation, as tolerated
with assistance medical immobilization by nursing staff, as required
eggcrate mattress (as indicated)
• No heavy lifting for the two (2) months following surgery
• Walking should be done frequently
• Patient can bathe and/or shower after five (5) days
• No sports for the first three (3) months following surgery
• NO twisting
The implant remains in the patient for a minimum of two years. Should the
patient require emergency medical attention during this period, the following
recommendations will apply:
• NO LOG ROLLING
• MedicAlert ® identification is recommended
• Deep breathing and incentive spirometry every hour while awake
• MRI of the chest or upper abdomen can be performed.
Day 2 Post-Op
• Cardiac defibrillation, if necessary, is performed with anterior/posterior
paddle placement to deliver electrical charge to the heart
• NO chest or waist bending
• OOB to a chair with assistance
• OOB ambulation, as tolerated with assistance supine with hip flexion
• NO chest or waist bending
• NO twisting
• NO LOG ROLLING
• Deep breathing and incentive spirometry every hour while awake
Day 3 Post-Op through Discharge Day
• OOB ambulation with minimal assistance supine with hip flexion
• NO chest or waist bending
• NO twisting
• NO LOG ROLLING
• Deep breathing and incentive spirometry every hour while awake
The patient should visit the doctor at regular intervals for evaluation of the
chest wall. The implant is removed when the chest wall is deemed strong
enough to support the sternum. Generally, the bar will remain implanted for
a minimum of 2 years, up to a maximum of 3 years following the procedure
Bar Removal
1. Surgery for removal of the support bar(s) and stabilizer(s) is performed
under general anesthesia as an outpatient procedure. The patient is in
the supine position with the arms abducted. Incisions are made in the
same locations as during the implantation.
2. The incision will allow access to the lateral tip of the support bar for
removal of all stabilizers and any remaining sutures. The support bar is
removed by pulling the bar through one incision while rolling the patient
to the opposite side.
3. The incisions are closed with absorbable sutures, and a postoperative
chest radiograph is recommended.
Ordering Information
Pectus Bar Implant
Size in Inches
Size in cm
Part #
Template Part #
7
17.8
01-3707
01-3807
8
20.3
01-3708
01-3808
9
22.9
01-3709
01-3809
10
25.4
01-3710
01-3810
10.5
26.7
01-3710-05
N/A
11
27.9
01-3711
01-3811
11.5
29.5
01-3711-05
N/A
12
30.5
01-3712
01-3812
12.5
31.8
01-3712-05
N/A
13
33.0
01-3713
01-3813
13.5
34.3
01-3713-05
N/A
14
35.6
01-3714
01-3814
14.5
36.8
01-3714-05
N/A
15
38.1
01-3715
01-3815
15.5
39.4
01-3715-05
N/A
16
40.6
01-3716
01-3816
17
43.2
01-3717
01-3817
Pectus Bar Implant
(See chart for details)
Standard
Container
01-3920
X-Long
Container
01-3925
Pectus Removal
Benders, Pair
01-3911
Elongated
Pectus Stabilizer
01-3801
LactoSorb®
Stabilizer
01-3805
*Patient specific size bars are available; please contact customer service.
Note: Templates are not implantable and should be used for surgical planning only.
Pectus Table Top Bender
01-3906
Pectus Introducer
Small (18.8”)
01-3909
Large (20”)
01-3908
X-large (22.4”)
01-3908X
Pectus Bender
01-3905
Pectus Bender
X-Long
01-3907
Pectus Flipper
01-3900
Warnings and Precautions for Pectus Support Bar System
Description
The Biomet Microfixation Pectus Support Bar and stabilizers are surgical
implants intended to aid treatment of Pectus Excavatum deformity. The
Pectus Support Bar provides the surgeon with a means to reposition bony
structures (sternum, breastbone) by applying internal force outwardly
eliminating the funnel shape deformity. The device should be removed
when remodeling is evident. The Pectus Support Bar and stabilizers are
made from Stainless Steel, ASTM F 138.
Indications
Pectus Excavatum and other sternal deformities.
Contraindications
1. Patients with mental or neurological conditions who are unwilling
or incapable of following instructions.
2. Patients presenting metal sensitivity reactions.
3. Patients with insufficient quantity or quality of bone or fibrous
tissue to allow remodeling.
4. Infection
Warnings and Precautions
The Pectus Support Bar provides the surgeon with a means of treating
Pectus Excavatum, funnel chest, a congenital deformity often
accompanied by shortness of breath in children. The device is not
intended to replace chest wall structures. While the device is intended
to expand the chest wall cavity eliminating the features of the deformity,
the degree of initial reshaping and permanent remodeling for each case
cannot be predetermined. The surgeon is to be thoroughly familiar with
the implants and the surgical procedure prior to surgery. The correct
selection and placement of the implant is important. Preoperative
planning to determine the most appropriate size and final position of the
implant is required. The surgeon should avoid sharp bends, reverse bends,
or bending the device at a hole. The implant can become dislodged,
shift, or flip as a result of improper device selection, improper stabilization,
not suturing the device(s), or patient activity too soon after surgery.
Even though the implant is mechanically fixed (sutured) in position, care
is to be taken to assure that the device is rigidly in apposition to the area
of the deformity, as demonstrated by total or partial elimination of the
visible deformity. If the deformity is not partially eliminated, a secondary
Pectus Support Bar may be required or an alternative method of treatment
is to be considered. During the course of the surgical procedure, and
during implantation, extreme care is to be taken to avoid contact with
the heart and lungs with either the implant or instruments, as contact to
these organs can cause death or permanent injury to the patient. When
considering removal, the surgeon should weigh the risks verses benefits
when deciding when to remove the implant. Where evidence of adequate
remolding is present, removal should be performed. Implant removal is to
be followed by post operative monitoring to check for reoccurrence of the
deformity. Where reoccurrence is encountered, a secondary treatment
or alternative treatment maybe necessary. Surgical implants should never
be reused. Even though the implant may appear undamaged, it may
have imperfections, defects, or internal stress patterns which may lead to
breakage or inadequate performance.
Patient Warnings
Post operative care and monitoring is important. Metallic fixation devices
cannot withstand activity levels and loads equal to those placed on a
normal healthy chest wall. The implant can loosen, migrate, bend, or break
as a result of weight bearing, load bearing, strenuous activity, or traumatic
injury. The patient is to be warned by the operating surgeon to limit
activities accordingly. Limitation of physical activities may be unique to
each patient and the patient should be warned that noncompliance with
post operative instructions could lead to complications described above.
The patient must be made aware and warned that the deformity or some
degree of deformity may be present even after treatment. In addition,
the patient is to be warned of general surgical risks and possible adverse
effects as listed, prior to surgery.
Possible Adverse Effects
1. Metal sensitivity reactions or allergic reaction to the implant material.
2. Pain, discomfort, or abnormal sensation due to the presence
of the device.
3. Surgical trauma; permanent or temporary nerve damage,
permanent or temporary damage to heart, lungs, and other
organs, body structures or tissues.
Caution: Federal Law (USA) restricts this device to sale by or on the order
of a licensed physician.
Operating Surgeons and all personnel involved with handling these products
are responsible for attaining appropriate education and training within the
scope of the activities with which they are involved in the handling and use
of this product.
Pectus Bar Technique Taken from:
5. Fracture, breakage, migration, or loosening of the implant.
1.Nuss D, Kelly RE, Croitoru D, Katz M. “A 10-Year Review of a Minimally
Invasive Technique for the Correction of Pectus Excavatum.” Journal of
Pediatric Surgery, Vol 33, No 4 (April), 1998: pp 545-552.
6. Inadequate or incomplete remodeling of the deformity or
return of deformity, prior to or after removal of implant.
“The Nuss Procedure” video, Children’s Hospital of the King’s Daughters
and Eastern Virginia Medical School, 1998.
7. Permanent injury or death.
Please refer to the product insert for full explanation of warnings and
considerations. Strength testing conducted at Biomet Microfixation,
Jacksonville, FL.
4. Skin irritation, infection, and pneumothorax.
Sterility
Steam sterilize the Pectus Support Bar prior to implantation using steam
sterilization equipment which has been properly validated. Following is
a recommended minimum cycle for steam sterilization that has been
validated by Biomet Microfixation under laboratory conditions. Individual
users must validate the cleaning and autoclaving procedures used
on-site, including the on-site validation of recommended minimum
cycle parameters described below.
Pre-vacuumed Steam Sterilization (Hi-VAC) Wrapped:
Temperature: Time: Drying Time: 270° Fahrenheit (132º Celsius)
Four (4) minutes
Thirty (30) minutes MINIMUM
Health care personnel bear the ultimate responsibility for ensuring
that any packaging method or material, including a reusable rigid
container system, is suitable for use in sterilization processing and sterility
maintenance in a particular health care facility. Testing should be
conducted in the health care facility to assure that conditions essential
to sterilization can be achieved. Since Biomet Microfixation is not familiar
with individual hospital handling methods, cleaning methods and
bioburden, Biomet Microfixation cannot assume responsibility for sterility
even though the guideline is followed.
Physicians Address:
Donald Nuss, M.B., Ch.B., F.A.C.S., (C), F.A.A.P.
601 Children’s Lane, Suite 5B
Norfolk, VA 23507